The Unknown Patient has been asked by many of his fellow myeloma fighters about when Revlimid (also known as Lenolidomide and CC-5013) will become available. Revlimid has been in the news recently because of successes in clinical trials for myeloma. It is said to work very well and have many fewer side effects than thalidomide. Revlimid could potentially offer options for people for whom other drugs, including thalidomide, have stopped working. It could also be an alternative for people who can’t tolerate the side effects of their current therapies.

Revlimid is a "thalidomide analog," meaning that its chemical formulation is based on thalidomide, but intended to remove the parts of the thalidomide molecule that cause that drug's most serious side effects (e.g., birth defects, neuropathy, and constipation) while retaining the parts that make it effective against myeloma.

However, for those of you thinking that this sounds like Revlimid won’t be available for a long time, think again. There are a number of ways Revlimid could soon be available to those who need it.

First, the Unknown Patient spoke with a number of senior people from Celgene in Sydney and then in Orlando . They assured him that there is an "Expanded Access Program" (EAP) being put in place. The EAP protocol has been submitted to the FDA and has a 30 day turnaround time. Looking at what needs to happen if/when the FDA notifies Celegene about proceeding with the program, Celgene expects it will likely make Revlimid available on a limited basis via the EAP as early as mid-July. An EAP is a mechanism for making unapproved drugs with clear benefit available to patients who have a specific need before approval. EAP programs benefit patients by providing early access to drugs that have been shown to be safe and effective in clincical trials while the FDA is reviewing their application for approval. They are also used to gather more data on drug safety before the drug is introduced broadly into the market. Important details about this program (eligibility criteria, size of the program, firm roll out dates) remain Unknown but more information should be available soon.

In reality, all use of thalidomide in the US today is "off label" as thalidomide has only been approved for treatment of leprosy. It has never been approved for myeloma. The application for thalidomide approval is currently being reviewed by the FDA. This past October, the FDA sent Celgene an “approvable letter” saying that the drug could be approved for myeloma if further data from a trial completed by the Eastern Cooperative Oncology Group were submitted to the FDA for review. The timing of this submission or the decision on thalidomide is unclear at this point.

So, it could be that Revlimid will follow a similar path of "off label" usage if it is approved for MDS. The difference is that Revlimid could be approved for myeloma within the year following the potential MDS approval date.

Bottom line, we can be hopeful that Revlimid will become available to myeloma patients on a limited basis this summer as part of an EAP, with broad availability sometime later this year if it is approved for MDS.

The Unknown Patient is sorry he had to use all that Unknown mumbo-jumbo to explain what's up with Revlimid. He hopes this report was understandable and helpful.

Randomized Phase III Study Comparing Conventional-Dose Treatment Using a Combination of Lenalidomide (Revlimid®), Bortezomib (Velcade®), and Dexamethasone (RVD) to High-Dose Treatment with Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age

Revlimid Webcasts from American Society of Hematology (ASH) Meeting 2011

This study, sponsored by Dr. Paul Richardson of the Dana-Farber Cancer Institute, was designed to answer a very important question in myeloma: In the era of novel drugs, is high-dose therapy (HDT) still necessary in the initial management of multiple myeloma in younger patients? In this study, the addition of HDT to conventional dose treatment (RVD) as compared to conventional-dose treatment (RVD) alone would be considered superior if it significantly prolongs progression-free survival by at least 9 months.

Celgene's Patient Support Coordinators assist patients and healthcare providers to navigate the challenges of reimbursement, provide information about co-pay assistance, and answer general questions about Revlimid.

Revlimid® is an immunomodulatory agent. It is a drug that can modify or regulate the functioning of the immune system. These agents appear to have multiple actions, including both anticancer and anti-inflammatory activities.

A quarterly publication featuring the most up-to-date information on research advances and new therapies for the treatment for multiple myeloma. CITINGS provides physicians and other health care professionals with references and Internet links to the most current U.S. and international journal articles, abstracts, and white papers. Several issues have been published on Revlimid™.

There was important news for myeloma patients this week as the US Food and Drug Administration approved Revlimid in combination with dexamethasone for newly diagnosed myeloma patients. Revlimid has already been in frontline use off-label in the US, but as IMF Chairman Dr. Brian Durie writes, the new approval raises “many issues which will limit ideal global access and use.” CLICK HERE to read Dr. Durie's blog.

Research presented at the British Society for Haematology Annual Meeting demonstrates that REVLIMID® has the ability to add years to myeloma patients’ lives, and that these years fall within the quality-adjusted life years, or QALY guidelines. QALY is a measurement of cost-effectiveness of a drug based on quality of life achieved, not just the number of years.

We are pleased that REVLIMID has been approved, but we are concerned about the high cost of cancer therapies in the current reimbursement environment. On the International Myeloma Foundation hotline we hear daily from myeloma patients who are forced to choose medical alternatives when costs are too high and reimbursement too low. We will look into reimbursement for Revlimid and coverage under the various Medicare plans and help our patients through the system. As patient advocates we will work with Celgene, with other pharmaceutical companies, and the government to help ensure that therapies are available to all who need them and are not out of reach because of price or reimbursement.

The International Myeloma Foundation – supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians - today said FDA approval of REVLIMID® (lenalidomide) for patients with myeloma is a major new addition to the group of treatments that together have the potential to significantly extend patients' lives.

Breakthroughs in the treatment of blood cancer were presented at the American Society of Clinical Oncology (ASCO) meeting in Atlanta. In one of the findings, Revlimid® was shown to extend life for patients taking the drug. This is a major advancement as the majority of multiple myeloma can now consider multiple myeloma a chronic, manageable condition. Video featuring patients Hardy Jones and Paul Nicholss and the IMF's Dr. Brian Durie.

Revlimid® (Lenalidomide) is an important new agent for the treatment of myeloma. It has shown great promise as both a single agent and in combination with dexamethasone and other drugs. With use of Revlimid there is much less risk of nerve toxicity than with thalidomide, which is one of the reasons patients have been eagerly awaiting access to it.

Revlimid from the Celgene Corporation was just approved by the Food and Drug Administration to treat certain patients with a malignant blood condition called myelodysplastic syndrom (MDS.) The IMF looks forward to rapid review of Revlimid for Multiple Myeloma.

An Independent Data Monitoring Board has advised Celgene to unblind two Phase III clinical trials of Revlimid (lenalidomide) in patients with relapsed or refractory myeloma involving over 700 patients. The results are positive and exceed original expectations.